Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04832503
Status:
COMPLETED
Last Update Posted:
2023-10-24
First Post:
2021-02-20
Brief Title:
Childhood Apraxia of Speech Experience Dependent Changes Induced by Treatment
Sponsor:
IRCCS Fondazione Stella Maris
Organization:
IRCCS Fondazione Stella Maris
Study Overview
Official Title:
Childhood Apraxia of Speech Neurobiological and Behavioural Markers and Experience Dependent Changes of Neural Connectivity Induced by Treatment
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAS
Brief Summary:
Childhood Apraxia of Speech CAS is a severe speech-language disorder whose aetiological neuroanatomical correlates are largely unknown Furthermore little is known about the neuroplastic effects induced by different treatment approaches and their relationships with the potential changes in the speech behavioural features that express the core deficit of CAS
Twenty four children with idiopathic CAS will be enrolled in a multidisciplinary study aimed at analysing the behavioural and neuroanatomical effects of a specific rehabilitative approach PROMPT PROMPTs for Restructuring Oral Muscular Phonetic Targets that employs tactile-kinesthetic-proprioceptive cues vs a traditional speech-language treatment The children will be allocated in two arms one receiving a seven month cycle of individual PROMPT treatment the other a traditional speech and language treatment for the same amount of timeThe pre- and post-treatment speech and language performances and DTI and volumetric MR data will be compared in the two groups
Twenty four children with idiopathic CAS will be enrolled in a multidisciplinary study aimed at analysing the behavioural and neuroanatomical effects of a specific rehabilitative approach PROMPT PROMPTs for Restructuring Oral Muscular Phonetic Targets that employs tactile-kinesthetic-proprioceptive cues vs a traditional speech-language treatment The children will be allocated in two arms one receiving a seven month cycle of individual PROMPT treatment the other a traditional speech and language treatment for the same amount of timeThe pre- and post-treatment speech and language performances and DTI and volumetric MR data will be compared in the two groups
Detailed Description:
Background Childhood Apraxia of Speech CAS is a severe speech-language disorder whose etiological neuroanatomical and genetic correlates are largely unknown In this trial the effects of an innovative rehabilitative approach PROMPT PROMPTS for Restructuring Oral Muscular Phonetic Targets will be evaluated from a behavioral and neuroanatomical point of view
Objective the current study is aimed to assess speech-language and white matter microstructure and volumetric changes induced by the PROMPT treatment
Participants Twenty-two Children with CAS aged 4 -12 years are enrolled and assigned to a PROMPT treatment PROMPT-t or a Language and Non-Speech Oral Motor-treatment group LNSOM-t
Methods All children with CAS will undergo a comprehensive clinical neurological and speech-language assessment The following procedures will be applied a anamnestic interview b oral non verbal and verbal movements eveluation c phonetic inventory accuracy and consistency of speech d DDK Diadochokinetic rate receptive and expressive vocabulary and grammar tests f spontaneous language analysis These multiple measurements were aggregated and converted into a speech and language composite score
MRI data will be acquired using a 15 T MR scanner Structural images obtained with a 3D isotropic T1 weighted sequence will be analysed to evaluate volumetric alterations to investigate cortical thickness and automatically delineate various Regions of Interest ROIs HARDI images will be acquired using 32 gradient directions and will be processed using tools available in FSL and MRtrix Tract-based spatial statistics TBSS will be used to statistically analyse images of FA and mean diffusivity Fiber tracts will be calculated using constrained spherical deconvolution and probabilistic tractography Connectomes will be calculated by combining ROIs obtained from the structural images with tractography Network-based analysis will be used to statistically analyse connectomes
Speech and language assessment and brain MRI VBM and DTI analysis will be performed at baseline and at the end of the treatment
Statistical analysis Paired t-test on pre and post treatment behavioural and MRIDTI measures will be performed to assess the changes within each of the two groups Moreover comparisons between the two groups at T0 and T1 will be performed by means of non parametric tests
Evaluation of potentially training-induced changes of brain structural connectivity may provide further support to the hypothesis that CAS is due to a disruption of networks subserving the speech production system
Objective the current study is aimed to assess speech-language and white matter microstructure and volumetric changes induced by the PROMPT treatment
Participants Twenty-two Children with CAS aged 4 -12 years are enrolled and assigned to a PROMPT treatment PROMPT-t or a Language and Non-Speech Oral Motor-treatment group LNSOM-t
Methods All children with CAS will undergo a comprehensive clinical neurological and speech-language assessment The following procedures will be applied a anamnestic interview b oral non verbal and verbal movements eveluation c phonetic inventory accuracy and consistency of speech d DDK Diadochokinetic rate receptive and expressive vocabulary and grammar tests f spontaneous language analysis These multiple measurements were aggregated and converted into a speech and language composite score
MRI data will be acquired using a 15 T MR scanner Structural images obtained with a 3D isotropic T1 weighted sequence will be analysed to evaluate volumetric alterations to investigate cortical thickness and automatically delineate various Regions of Interest ROIs HARDI images will be acquired using 32 gradient directions and will be processed using tools available in FSL and MRtrix Tract-based spatial statistics TBSS will be used to statistically analyse images of FA and mean diffusivity Fiber tracts will be calculated using constrained spherical deconvolution and probabilistic tractography Connectomes will be calculated by combining ROIs obtained from the structural images with tractography Network-based analysis will be used to statistically analyse connectomes
Speech and language assessment and brain MRI VBM and DTI analysis will be performed at baseline and at the end of the treatment
Statistical analysis Paired t-test on pre and post treatment behavioural and MRIDTI measures will be performed to assess the changes within each of the two groups Moreover comparisons between the two groups at T0 and T1 will be performed by means of non parametric tests
Evaluation of potentially training-induced changes of brain structural connectivity may provide further support to the hypothesis that CAS is due to a disruption of networks subserving the speech production system
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None